The nation put resources and manpower behind the mission before it even knew if the vaccines would work. Less than a year after the first known cases of Covid-19 reached this country, the United States had developed and authorized the first Covid-19 vaccines for emergency use.
This is not the typical development process for vaccines, which typically go through a lengthy US Food and Drug Administration approval process. But the urgency of the pandemic called for a deviation from the norm, as the nation in crisis awaited vaccines that would mean a new, hopefully brighter chapter for the country and the world. And so, instead of seeking traditional FDA approval, Pfizer, Moderna, and a few months later Janssen applied for Emergency Use Clearance (EUA) from the FDA.
The FDA’s Emergency Use Clearance, a process that has been used time and time again before, has resulted in the widespread delivery of effective and rigorously tested Covid-19 vaccines to millions of Americans during a pandemic that killed more than 580,000 people in the United States. Anyone who would have hesitated in obtaining the vaccine due to the lack of full FDA approval should be assured that vaccine developers were required to take additional safety measures. And now that the vaccine has been successfully deployed, states and private companies should think outside the box and help encourage vaccinations while focusing on expanding access to all Americans.
The FDA’s Emergency Use Clearance for Drugs, Biologics, and Devices was specifically created after the 9/11 terrorist attacks to ensure that in emergency situations, potentially life-saving medical products can be available quickly without lengthy approval processes. The EUA authority has been used extensively in previous public health emergencies – including 22 products such as antivirals, respiratory protection devices, and diagnostic tests in response to the 2009 H1N1 pandemic – and the current pandemic to ensure expedited access to diagnostic tests and treatments such as remdesivir, which now has full FDA approval.
Readers may recall the political turmoil surrounding the decision on these additional security requirements, as it ensured that a Covid-19 vaccine would not be cleared until the November election. The review process itself was also as meticulous as ever, including the generally required independent manufacturer data oversight board, followed by independent assessment by FDA advisers and external advisory committees of the FDA. FDA and US Centers for Disease Control and Prevention.
The only unusual twist in the otherwise usual process was the deep transparency between sharing study protocols and live committee meetings.
As part of their EUA, manufacturers were required to continue clinical trials after receiving approval for additional safety and efficacy information before seeking approval – which typically includes at least 6 months of safety data. . Pfizer / BioNTech kicked off this process last Friday, making them the first Covid vaccine developers to gain full FDA approval.
In addition, manufacturers have been required to actively monitor safety to inform ongoing deliberations on the benefits and risks of vaccines. These systems have been shown to be extremely sensitive – enough to identify a rare event such as low platelet count blood clots occurring in individuals vaccinated with Johnson & Johnson at a rate of less than 5 per million. Real-world experience after more than 230 million doses of mRNA vaccines also confirmed study trial data of greater than 94% effectiveness in preventing hospitalization in fully vaccinated people, even among the elderly. Acute severe infections have been rare.
The exceptional benefit / risk profile of US vaccines is now firmly established, and vaccination was extended this week to young people aged 12 to 15 with more opportunities to expand community protection. Sadly, the new challenge in the United States is no longer a limited supply of vaccines, but a decrease in demand for vaccines is attributed, in large part, to a lack of confidence in vaccines and continued access challenges. . In April, 55% of adults received at least one dose of the vaccine, but 26% say they definitely won’t or only get vaccinated when needed. States are also still lagging behind in immunizing blacks and Hispanics, despite a larger supply of vaccines across the country.
The question now is how to improve confidence and access to vaccines, as well as other public health measures, in order to crush the pandemic and regain our collective freedoms. This is especially important because increasing immunization rates can reduce preventable daily deaths to close to zero. Meeting this challenge will require new tools, incentives and strategies to tackle the sheer hesitation, disinformation and outright lies communicated by bad actors, such as Russia’s disinformation campaign, or “Plandemic” – a “Documentary” debunked. No, Microsoft co-founder Bill Gates isn’t engaged in a decades-long conspiracy to control the world through vaccines, including creating the SARS-CoV-2 virus in a lab and spreading it. And no, the vaccine doesn’t have a tracking microchip, doesn’t cause infertility, and doesn’t make you a mutant. It also does not cause menstrual irregularities in unvaccinated people who come into contact with those who are vaccinated.
In fact, getting the vaccine prevents death, makes you a good citizen, and allows you to safely visit your elders, socialize with your vaccinated friends, travel, and remove your mask in many settings.
We’re already seeing creative incentives to get people vaccinated, including offering savings bonds, gift certificates, subway passes, baseball tickets, and free rides to appointments for kids. vaccines. Ohio is also running a statewide lottery for those who have been vaccinated, with a prize of up to $ 1 million or a full four-year scholarship for those under 18. get immunized by offering paid time off or childcare options.
States should also create mobile clinics to meet people where they are and improve access to vaccines by dramatically expanding access points throughout the health care system so people can get vaccinated. in any pharmacy or clinic – even when they are seeing the dentist, podiatrist or chiropractor. , for example.
And getting the vaccines officially approved by the FDA will also pave the way for mandatory vaccination programs to facilitate school and workplace health programs.
Vaccines are powerful. Get vaccinated now and, by then, mask yourself!